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CORK, Ireland, Sept. 15, 2021 /PRNewswire/ — Johnson Controls (NYSE: JCI), the global leader for smart, healthy and sustainable buildings, selected Tempered Networks to provide best-in-class secure communications and network management for its OpenBlue services, further advancing cybersecurity leadership for the company’s smart buildings technology ecosystem.

The agreement allows Johnson Controls to deploy Tempered Airwall as a core component of OpenBlue service offerings to protect building automation customers worldwide. OpenBlue serves many different industries including commercial and civic workplaces, hospitals, schools, campuses, and stadiums.

“The acceleration of digital transformation means our customers are realizing the benefits of operating smart buildings that are increasingly data-enabled and require the strongest levels of cybersecurity”, said Vijay Sankaran, vice president and chief technology officer at Johnson Controls. “By leveraging security technology from Tempered Networks, we enable smart buildings with industry-leading secure remote access technology and AI-driven security insights to help OpenBlue customers manage risk and simplify network management, allowing them to deliver a great occupant experience.”

Tempered Airwall will be integrated into OpenBlue Bridge technology, a gateway for secure edge to cloud communications.

“We are enabling Johnson Controls technicians to securely access and manage equipment at a customer site from anywhere using zero trust software defined networking and military-grade encryption, rendering building systems invisible to unauthorized users and potential attacks,” said Jason Christman, vice president and chief product security officer at
Johnson Controls.

Johnson Controls new OpenBlue services that leverage the Tempered Airwall platform will be available globally and addresses clear demand for improved cybersecurity and management.

“Critical infrastructure is being hacked daily because digital transformation has made it vulnerable.  The network solutions that worked in the past, like adding yet another firewall, are no longer effective”, said Keith Beeman, CEO of Tempered Networks.  “With Airwall’s native zero trust platform, building automation systems can now be safely and optimally managed from anywhere.”

The integration of Lynwood, Washington-based Tempered Network’s security technology further advances OpenBlue Services leadership in cybersecurity, building on recent partnerships with Pelion and DigiCert to provide advanced secure device management and digital trust for smart building technology.

To learn more about Johnson Controls’ approach to cybersecurity, please visit www.johnsoncontrols.com/cybersolutions. 

To learn more about Tempered Networks and Tempered Airwall, please visit https://tempered.io.

About Johnson Controls:

At Johnson Controls (NYSE: JCI) we transform the environments where people live, work, learn and play. As the global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet. 

With a history of more than 135 years of innovation, Johnson Controls delivers the blueprint of the future for industries such as healthcare, schools, data centers, airports, stadiums, manufacturing and beyond through its comprehensive digital offering OpenBlue. With a global team of 100,000 experts in more than 150 countries, Johnson Controls offers the world`s largest portfolio of building technology, software as well as service solutions with some of the most trusted names in the industry. For more information, visit www.johnsoncontrols.com or follow us @johnsoncontrols on Twitter.

About Tempered Networks

Tempered Airwall protects critical infrastructure with the industry’s only, truly native Zero Trust platform. Think of us as the virtual air gap protecting the systems in a smart building, the medical devices in a hospital, the machines in a factory floor. These are all use cases we solve today. Airwall helps you easily secure things and facilities while still allowing you to monitor and connect to them remotely, from anywhere. For more information visit https://tempered.io.

Johnson
 
Controls
 
International plc Cautionary
 
Statement Regarding Forward-Looking Statements
Johnson Controls International plc has made statements in this communication that are forward-looking and therefore are subject to risks and uncertainties. All statements in this document other than statements of historical fact are, or could be, “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In this communication, statements regarding Johnson Controls’ future financial position, sales, costs, earnings, cash flows, other measures of results of operations, synergies and integration opportunities, capital expenditures and debt levels are forward-looking statements. Words such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “should,” “forecast,” “project” or “plan” and terms of similar meaning are also generally intended to identify forward-looking statements. However, the absence of these words does not mean that a statement is not forward-looking. Johnson Controls cautions that these statements are subject to numerous important risks, uncertainties, assumptions and other factors, some of which are beyond Johnson Controls’ control, that could cause Johnson Controls’ actual results to differ materially from those expressed or implied by such forward-looking statements, including, among others, risks related to: Johnson Controls’ ability to manage general economic, business, capital market and geopolitical conditions, including global inflation and component shortages; Johnson Controls’ ability to manage the impacts of natural disasters, climate change, pandemics and outbreaks of contagious diseases and other adverse public health developments, such as the COVID-19 pandemic; the strength of the U.S. or other economies; changes or uncertainty in laws, regulations, rates, policies or interpretations that impact Johnson Controls’ business operations or tax status; the ability to develop or acquire new products and technologies that achieve market acceptance; changes to laws or policies governing foreign trade, including increased tariffs or trade restrictions; maintaining the capacity, reliability and security of Johnson Controls’ enterprise and product information technology infrastructure; the risk of infringement or expiration of intellectual property rights; any delay or inability of Johnson Controls to realize the expected benefits and synergies of recent portfolio transactions such as its merger with Tyco and the disposition of the Power Solutions business;  the outcome of litigation and governmental proceedings; the ability to hire and retain key senior management; the tax treatment of recent portfolio transactions; significant transaction costs and/or unknown liabilities associated with such transactions; the availability of raw materials and component products; fluctuations in currency exchange rates; labor shortages, work stoppages, union negotiations, labor disputes and other matters associated with the labor force; the cancellation of or changes to commercial arrangements.  A detailed discussion of risks related to Johnson Controls’ business is included in the section entitled “Risk Factors” in Johnson Controls’ Annual Report on Form 10-K for the year ended September 30, 2020 filed with the United States Securities and Exchange Commission (“SEC”) on November 16, 2020, which is available at www.sec.gov and www.johnsoncontrols.com under the “Investors” tab. Shareholders, potential investors and others should consider these factors in evaluating the forward-looking statements and should not place undue reliance on such statements. The forward-looking statements included in this communication are made only as of the date of this document, unless otherwise specified, and, except as required by law, Johnson Controls assumes no obligation, and disclaims any obligation, to update such statements to reflect events or circumstances occurring after the date of this communication.

Forward Looking Non-GAAP Financial Metrics
The Company has presented forward-looking statements regarding, organic revenue growth, adjusted segment EBITA margin, and adjusted earnings per share, which are non-GAAP financial measures. These forward-looking non-GAAP financial measures are derived by excluding certain amounts, expenses, or income from the corresponding financial measures determined in accordance with GAAP. The Company defines organic revenue growth as revenue growth excluding the effect of acquisitions, divestitures and foreign currency. The Company defines segment EBITA as income (loss) from continuing operations before income taxes and noncontrolling interests, excluding general corporate expenses, intangible asset amortization, net financing charges, restructuring and impairment costs, and the net mark-to-market adjustments related to restricted asbestos investments and pension and postretirement plans. Adjusted segment EBITA excludes special items because these items are not considered to be directly related to the underlying operating performance of the Company’s businesses. Management believes that organic growth, segment EBITA, adjusted segment EBITA and adjusted segment EBITA margin are useful to investors in understanding the ongoing operations and business trends of the Company. Free cash flow is defined as cash provided by operating activities less capital expenditures. Free cash flow conversion is defined as adjusted free cash flow divided by adjusted net income. Management believes these non-GAAP measures are useful to investors in understanding the strength of the Company and its ability to generate cash. Adjusted earnings per share is defined as earnings per share, less integration costs, net mark-to-market adjustments, restructuring and impairment costs, transaction costs and other nonrecurring costs, Power Solutions divestiture reserve adjustment and discrete tax items. The Company excludes these items because they are not considered to be directly related to the underlying operating performance of the Company. Management believes adjusted EPS is useful to investors in understanding the ongoing operations and business trends of the Company.

The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts recognized in a given period, including but not limited to the high variability of the net mark-to-market adjustments and the effect of foreign currency exchange fluctuations. Our fiscal 2021 full year and fiscal 2022-2024 guidance for organic revenue also excludes the effect of acquisitions, divestitures and foreign currency.  

We are unable to present a quantitative reconciliation of the aforementioned forward-looking non-GAAP financial measures to their most directly comparable forward-looking GAAP financial measures because such information is not available and management cannot reliably predict all of the necessary components of such GAAP measures without unreasonable effort or expense. The unavailable information could have a significant impact on the Company’s GAAP financial results.

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SOURCE Johnson Controls International plc

TAMPA, Fla., Sept. 15, 2021 /PRNewswire/ – Primo Water Corporation (NYSE: PRMW) (TSX: PRMW) (the “Company” or “Primo”), a leading provider of sustainable drinking water solutions direct to consumers in North America and Europe, today announced that it has entered into an agreement to purchase a minority interest in Sipple Hydration Stations, an innovative network of hydration stations in the UK providing purified & super chilled premium water refills.

The agreement allows Primo to participate in the growing UK market and to expand the Sipple Hydration Stations to other markets in Primo’s footprint. Customers can use their own bottle to refill, or they can purchase a reusable bottle from the hydration station along with one free 500ml refill. 

“Sipple hydration stations are a convenient way to offer an affordable, plastic-free alternative to our customers, meeting a key environmental and hygienic need by supplying great tasting, purified, chilled water on the move without the waste of traditional, single-use plastic bottles,” said Tom Harrington, CEO of Primo Water Corporation. “Sipple shares our vision of reducing plastic waste, while increasing the consumption of safe, high quality drinking water. This investment furthers our vision of providing pure-play water solutions whenever, wherever and however our customers want them.”

Primo is headquartered in Tampa, Florida (USA). For more information, visit www.primowatercorp.com or Sipple Hydration Stations.

ABOUT PRIMO WATER CORPORATION

Primo Water Corporation is a leading pure-play water solutions provider in North America, Europe and Israel and generates approximately $2.0 billion in annual revenue. Primo operates largely under a recurring razor/razorblade revenue model. The razor in Primo’s revenue model is its industry leading line-up of sleek and innovative water dispensers, which are sold through major retailers and online at various price points or leased to customers. The dispensers help increase household penetration which drives recurring purchases of Primo’s razorblade offering. Primo’s razorblade offering is comprised of Water Direct, Water Exchange, and Water Refill. Through its market leading Water Direct business, Primo delivers sustainable hydration solutions across its 22-country footprint direct to the customer’s door, whether at home or to commercial businesses. Through its market leading Water Exchange and Water Refill businesses, Primo offers pre-filled and reusable containers at over 13,000 locations and water refill units at approximately 22,000 locations, respectively. Primo also offers water filtration units across its 22-country footprint representing a top five position.

Primo’s water solutions expand consumer access to purified, spring and mineral water to promote a healthier, more sustainable lifestyle while simultaneously reducing plastic waste and pollution. Primo is committed to its water stewardship standards and is proud to partner with the International Bottled Water Association (IBWA) in North America as well as with Watercoolers Europe (WE), which ensure strict adherence to safety, quality, sanitation and regulatory standards for the benefit of consumer protection.

Primo is headquartered in Tampa, Florida (USA). For more information, visit www.primowatercorp.com.

Safe Harbor Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 conveying management’s expectations as to the future based on plans, estimates and projections at the time Primo makes the statements. Forward-looking statements involve inherent risks and uncertainties and Primo cautions you that several important factors could cause actual results to differ materially from those contained in any such forward-looking statement. The forward-looking statements contained in this press release include, but are not limited to, statements related to the investment in Sipple and related matters. The forward-looking statements are based on assumptions regarding management’s current plans and estimates. Management believes these assumptions to be reasonable, but there is no assurance that they will prove to be accurate.

Factors that could cause actual results to differ materially from those described in this press release include, among others: risks relating to any unforeseen changes to or effects on liabilities, future capital expenditures, revenues, expenses, earnings, synergies, indebtedness, financial condition, losses and future prospects; the effect of economic, competitive, legal, governmental and technological factors on Primo’s business; and the impact of national, regional and global events on our business, including the recent COVID-19 outbreak.

The foregoing list of factors is not exhaustive. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. Readers are urged to carefully review and consider the various disclosures, including but not limited to risk factors contained in Primo’s Annual Report on Form 10-K and its quarterly reports on Form 10-Q, as well as other filings with the securities commissions.

Primo does not undertake to update or revise any of these statements considering new information or future events, except as expressly required by applicable law.

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SOURCE Primo Water Corporation

LONDON, Sept. 15, 2021 /PRNewswire/ — International Game Technology PLC (“IGT”) (NYSE: IGT) announced today that the Company is extending its momentum in cashless gaming technology deployments to Oklahoma, the U.S. state with the second-highest concentration of gaming machines per capita. Indigo Sky Casino in Wyandotte, Okla. is the latest casino to join the cashless gaming revolution by way of a multi-year agreement with IGT and a phased rollout of the Resort Wallet and IGTPay modules of the IGT ADVANTAGE^® casino management system.

By combining Resort Wallet technology with the IGTPay solution, Indigo Sky Casino will offer its patrons convenient, one-step access to funds from external sources such as credit and debit cards, bank accounts, and eWallets.

“Enhancing Indigo Sky Casino’s IGT ADVANTAGE deployment with IGT’s Resort Wallet and IGTPay modules will truly differentiate our gaming experience in Oklahoma and give our guests access to the industry’s most user-friendly cashless gaming technology,” saidMelanie Heskett, Indigo Sky Casino General Manager. “As the demand for cashless and contactless payment technologies accelerates in nearly every sector, Indigo Sky Casino is pleased to be an early mover in this space by partnering with our long-time growth partner, IGT.”

“In deploying IGT’s Resort Wallet and IGTPay, Indigo Sky Casino will benefit from the many advantages of operating a cashless gaming ecosystem and its guests will enjoy added choice and convenience on the casino floor,” said Ryan Reddy, IGT Senior Vice President Global Product Management for VLT, Poker, Systems and Payments. “Launching Resort Wallet and IGTPay in Oklahoma, one of the country’s premier tribal gaming markets, reflects IGT’s continued leadership in the digital payments space and the versatility of the IGT ADVANTAGE casino management system and modules.”

Indigo Sky Casino plans to initiate the rollout of IGT’s full gaming solution in 2021.The technology stack includes the option for “carded cashless” and “cardless cashless” gaming. With carded cashless, the player will leverage his or her physical GO Rewards loyalty card and insert it into a slot machine to transfer funds, fund play, cash out and check account balances. In the cardless cashless model, Indigo Sky Casino patrons will have the option to use the property’s mobile app to complete all payment-related actions safely and securely.

In both configurations, Indigo Sky Casino players will create a PIN-protected Cashless Wagering Account where they can fund their accounts at the casino cage or slot machine or through external sources such as bank accounts and credit or debit cards. Funds in the Cashless Wagering Account are securely maintained for the next play session or property visit, and players can also transfer funds between slot machines on site or withdraw funds into a bank account. IGT’s experienced Payments team will support Indigo Sky Casino, managing all aspects of payment-related services such as contracting with payment services providers, funds management, fraud/risk management, and player support.

For more information, visit igt.com/cashless, or go to Facebook at facebook.com/IGT, follow us on Twitter at twitter.com/IGTnews, or watch IGT videos on YouTube at youtube.com/igt. 

About IGT
IGT (NYSE:IGT) is the global leader in gaming. We deliver entertaining and responsible gaming experiences for players across all channels and regulated segments, from Gaming Machines and Lotteries to Sports Betting and Digital. Leveraging a wealth of compelling content, substantial investment in innovation, player insights, operational expertise, and leading-edge technology, our solutions deliver unrivaled gaming experiences that engage players and drive growth. We have a well-established local presence and relationships with governments and regulators in more than 100 countries around the world, and create value by adhering to the highest standards of service, integrity, and responsibility. IGT has approximately 11,000 employees. For more information, please visit www.igt.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release may contain forward-looking statements (including within the meaning of the Private Securities Litigation Reform Act of 1995) concerning International Game Technology PLC and its consolidated subsidiaries (the “Company”) and other matters. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, dividends, results of operations, or financial condition, or otherwise, based on current beliefs of the management of the Company as well as assumptions made by, and information currently available to, such management. Forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “plan,” “could,” “would,” “should,” “shall”, “continue,” “estimate,” “expect,” “forecast,” “future,” “guidance,” “intend,” “may,” “will,” “possible,” “potential,” “predict,” “project” or the negative or other variations of them. These forward-looking statements speak only as of the date on which such statements are made and are subject to various risks and uncertainties, many of which are outside the Company’s control. Should one or more of these risks or uncertainties materialize, or should any of the underlying assumptions prove incorrect, actual results may differ materially from those predicted in the forward-looking statements and from past results, performance, or achievements. Therefore, you should not place undue reliance on such statements. Factors that could cause actual results to differ materially from those in the forward-looking statements include (but are not limited to) the factors and risks described in the Company’s annual report on Form 20-F for the financial year ended December 31, 2020 and other documents filed from time to time with the SEC, which are available on the SEC’s website at www.sec.gov and on the investor relations section of the Company’s website at www.IGT.com. Except as required under applicable law, the Company does not assume any obligation to update these forward-looking statements. You should carefully consider these factors and other risks and uncertainties that affect the Company’s business. All forward-looking statements contained in this news release are qualified in their entirety by this cautionary statement. All subsequent written or oral forward-looking statements attributable to International Game Technology PLC, or persons acting on its behalf, are expressly qualified in their entirety by this cautionary statement.

Contact:

Phil O’Shaughnessy, Global Communications, toll free in U.S./Canada +1 (844) IGT-7452; outside U.S./Canada +1 (401) 392-7452
Francesco Luti, +39 3485475493; for Italian media inquiries
James Hurley, Investor Relations, +1 (401) 392-7190

© 2021 IGT

The trademarks and/or service marks used herein are either trademarks or registered trademarks of IGT, its affiliates or its licensors.

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SOURCE International Game Technology PLC

INDIANAPOLIS, Sept. 15, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced an additional purchase by the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of the agreement, Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with approximately 200,000 doses expected to ship Q3 2021 and the remaining to be shipped in Q4. This transaction is expected to generate approximately $330 million in revenue in the second half of 2021.

“The recent increase in COVID-19 cases has caused a substantial rise in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates,” said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. “Lilly developed bamlanivimab and etesevimab for administration together, in anticipation of variants such as the highly contagious Delta variant, which currently accounts for more than 98 percent of all identified COVID-19 cases in the U.S.”

Pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab together retained neutralization activity against the Alpha and Delta variants. On September 2^nd, the Office of the Assistant Secretary for Preparedness and Response (ASPR), alongside the U.S. Food and Drug Administration (FDA), resumed the shipment and distribution of bamlanivimab and etesevimab administered together.

For more information about the use of bamlanivimab with etesevimab to treat COVID-19, click here or contact Lilly’s 24-hour support line at 1-855-LillyC19 (1-855-545-5921). For media resources, including product images and fact sheets, please click here.

The impact of this transaction will be reflected in the company’s financial results for Q3 and Q4 2021.

The purchase was funded by the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response through Department of Defense contract number W911QY21D0012.

Important Information about bamlanivimab and etesevimab together

Bamlanivimab and etesevimab together have not been approved by the FDA for any use. It is not known if bamlanivimab and etesevimab together are safe and effective for the treatment of COVID-19. 

Bamlanivimab and etesevimab together are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish) for bamlanivimab and etesevimab together.

Authorized Use and Important Safety Information


Bamlanivimab and etesevimab together are authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Limitations of Authorized Use


Combined Frequency of Variants Resistant to Bamlanivimab and Etesevimab

• Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%.¹
• A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website.

Use in Patients Who Are Hospitalized or Who Require Oxygen Due to COVID-19

Bamlanivimab and etesevimab together are not authorized for use in patients:

• who are hospitalized due to COVID-19, OR
• who require oxygen therapy due to COVID-19, OR
• who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.

Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Important Safety Information
There are limited clinical data available for bamlanivimab and etesevimab together. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together.

Warnings and Precautions


Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab and etesevimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions, occurring during or up to 24 hours after infusion, have been observed with administration of bamlanivimab and etesevimab together. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:

• fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. presyncope, syncope), dizziness, and diaphoresis.

Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of bamlanivimab and etesevimab under Emergency Use Authorization.

Clinical Worsening After Receiving Bamlanivimab and Etesevimab Administration
 
Clinical worsening of COVID-19 after administration of bamlanivimab and etesevimab together has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab and etesevimab use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

Adverse Reactions

Adverse reactions observed in those who have received bamlanivimab and etesevimab are anaphylaxis (n=1, 0.07%) and infusion-related reactions (n=16, 1.1%).  The most common treatment-emergent adverse events included nausea, dizziness, and pruritis.  No treatment-emergent events occurred in more than 1% of participants and rates were comparable to placebo.

Use in Specific Populations



Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab and etesevimab together should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

¹ FDA will make this determination considering current variant frequency data (available at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html), trends in variant frequency over time, the precision of the estimates and information regarding emerging variants of concern. FDA will update the list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized as new data and information becomes available. Healthcare providers should refer to the FDA website regularly for updates.

About bamlanivimab and etesevimab
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It was designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Bamlanivimab was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19. 

Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Results from a Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) were published in the New England Journal of Medicine. Results from a Phase 3 study of bamlanivimab in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) were published in the Journal of American Medical Association (JAMA). A Phase 2 study assessing the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting (BLAZE-4. NCT04634409) has completed enrollment.

About Lilly’s COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover and develop novel antibody therapies for COVID-19. Click here for resources related to Lilly’s COVID-19 efforts.

About Eli Lilly and Company
  
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news. P-LLY

Lilly Cautionary Statement Regarding Forward-Looking Statements 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together as a potential therapy for patients with COVID-19, the supply, distribution and contracts with governments relating to these therapies, and Lilly’s development plans, and reflects Lilly’s current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab and etesevimab together will prove to be a safe and effective treatment or successful preventative therapy for COVID-19, that bamlanivimab and etesevimab together will receive regulatory approvals or additional authorizations, that patients will volunteer to participate in clinical trials or achieve positive outcomes, that Lilly will obtain any additional purchase orders or supply contracts, or that Lilly can provide an adequate supply of bamlanivimab and etesevimab together in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, please see Lilly’s most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

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SOURCE Eli Lilly and Company